New FDA regulations and effect on DIY?

[rastapete69]

Do the new rules potentially have an impact on our ability to buy the ingredients for DIY?

I only live about 20 minutes from Wizard Labs and am wondering if I need to rent a UHaul and stock up for whatever time I have left on this planet?

 

[dannyv45]

This will end the sales of e-cigarette hardware and juices in the US and turn the e-cigarette business over to big tobacco. Better stock up now. It's a sad day for us vapors but we all knew it was coming.

 

[Vaslovik]

This will end the sales of e-cigarette hardware and juices in the US and turn the e-cigarette business over to big tobacco. Better stock up now. It's a sad day for us vapors but we all knew it was coming.

So this will mean I can't order nic from Nude Nicotine, or flavors either?

 

[rastapete69]

I'm hoping this is not true and can't figure out how they will control the flavorings, as they are also used as food flavorings in many cases.

The nicotine part has me concerned

 

[rastapete69]

I haven't had time, and I doubt I will, to read all 500 or so pages of the legislation.

While I am no fan of government interference in my hobby, the major points such as banning the sale to minors, and supplier ingredient check might actually be ok.

While I imagine it will cause small juice makers nightmares, I am mostly concerned with the sale of nicotine.

I emailed Wizard labs and am looking forward to their take.

 

[dannyv45]

So this will mean I can't order nic from Nude Nicotine, or flavors either?

Only if they submit to FDA testing and approval at 2 - 10 million a shot.

 

[dannyv45]

I'm hoping this is not true and can't figure out how they will control the flavorings, as they are also used as food flavorings in many cases.

The nicotine part has me concerned

If it is sold and labeled for vaping it will need FDA approval.

 

[Vaslovik]

If it is sold and labeled for vaping it will need FDA approval.

So they are going to destroy a huge industry for the sake of their hate I guess, and I can't even guess how many jobs will be lost to their greed, hatred, and ignorance.

 

[dannyv45]

I haven't had time, and I doubt I will, to read all 500 or so pages of the legislation.

While I am no fan of government interference in my hobby, the major points such as banning the sale to minors, and supplier ingredient check might actually be ok.

While I imagine it will cause small juice makers nightmares, I am mostly concerned with the sale of nicotine.

I emailed Wizard labs and am looking forward to their take.

I can understand limiting sale to under age people but FDA approval of all vaping hardware and ingredients at such a huge cost will put small manufactures and businesses out of business. And as the articles states big business such as big tobacco will be the only companies that will be able to afford this FDA testing. So what ever does make it to the market will be extreamly expensive to purchase (Look at the cost of cigarettes). It's as I've said all along about the governments mentality "If it don't make money then ban it". The governments concern about our health is nothing but a big joke. It's all about the money.

For those not up on this read about it here.

FDA unveils new regulations on e-cigarettes

and here

Vaporizers, E-Cigs, and other Electronic Nicotine Delivery Systems (ENDS)

 

[jambi]

So this will mean I can't order nic from Nude Nicotine, or flavors either?

Far as I understand it (and there's a lot I don't understand), you can forget about Nude Nicotine. Apparently, Alchem (Nic Select) already has FDA approval FDA APPROVAL LETTER but I'm not clear on whether it's for the product or just the facility. Alchem probably has resources to obtain FDA approval, but who knows if they'll decide the cost of doing so is justifiable. Stands to reason that if the (DIY) market is lucrative enough (doubtful at this point) big pharma will go ahead and field a liquid nic product, but I'd expect prices to rise significantly from what we're paying now, among other hassles...imagine only being able to buy nic base only by prescription from a pharmacy.

But I wouldn't hold much hope that Nude Nicotine or Carolina Extracts would have the resources to obtain FDA approval.

There should be no issue with synthetic flavorings, VG/PG. Hence, we'll probably see a shift in DIY suppliers over the next few months to business models like Bull City. Flavors, PG, VG, bottles, lab equipment, and that's it.

NETs, tobacco absolutes...any flavor derived from real tobacco will probably also be gone, at least initially.

Just my best guesses though. I have not read all 499 pages yet, and may not be correctly interpreting what I have read.

Edit...I have my inquiry in with Nicotine River (nicselect vendor) as well.

 

[Vaslovik]

While I imagine it will cause small juice makers nightmares, I am mostly concerned with the sale of nicotine.

I emailed Wizard labs and am looking forward to their take.

I emailed Nude Nicotine as well. I'm not sure I will get a reply as their website offers only 3 means of contacting them, Facebunk, Twitter, and Instagram, none of which I will have anything to do with. I just emailed their admin straight up. Hope to hear back from them.

 

[Susan~S]

@SmokeyJoe site, posting all day => Deeming Live blog | vaping.com

Thread on ECF: Deeming Regulations have been released!!!!

 

[dannyv45]

Far as I understand it (and there's a lot I don't understand), you can forget about Nude Nicotine. Apparently, Alchem (Nic Select) already has FDA approval FDA APPROVAL LETTER but I'm not clear on whether it's for the product or just the facility. Alchem probably has resources to obtain FDA approval, but who knows if they'll decide the cost of doing so is justifiable. Stands to reason that if the (DIY) market is lucrative enough (doubtful at this point) big pharma will go ahead and field a liquid nic product, but I'd expect prices to rise significantly from what we're paying now, among other hassles.

But I wouldn't hold much hope that Nude Nicotine or Carolina Extracts would have the resources to obtain FDA approval.

There should be no issue with synthetic flavorings, VG/PG. Hence, we'll probably see a shift in DIY suppliers over the next few months to business models like Bull City. Flavors, PG, VG, bottles, lab equipment, and that's it.

NETs, tobacco absolutes...any flavor derived from real tobacco will probably also be gone, at least initially.

Just my best guesses though. I have not read all 499 pages yet, and may not be correctly interpreting what I have read.

Flavorings marketed towards vaping are included see below even calculation software such as ejuce-me-up are included in this regulation. This regulation targets every aspect of e-cigarettes and vaping in general.

FDA Regulation of ENDS
In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigs), e-pipes, and all other ENDS. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS* but excludes accessories.

However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.

Components


Click for larger version

*“Components” or “parts” include, among other things, software or an assembly of materials intended or reasonably expected alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product. For a full definition of ENDS components, parts, and accessories, please read the Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. Examples of components and parts of ENDS include, but are not limited to:

• E-liquids
• A glass or plastic vial container of e-liquid
• Cartridges
• Atomizers
• Certain batteries
• Cartomizers and clearomizers
• Digital display or lights to adjust settings
• Tank systems
• Drip tips
• Flavorings for ENDS

 

[rastapete69]

my guess is that big tobacco will do the heavy lifting as far as getting ingredients approved, and small companies will, at best, need to verify their ingredients, which may be cost prohibitive.

As selfish as it may be, I am really concerned mostly about nicotine

 

[dannyv45]

my guess is that big tobacco will do the heavy lifting as far as getting ingredients approved, and small companies will, at best, need to verify their ingredients, which may be cost prohibitive.

As selfish as it may be, I am really concerned mostly about nicotine

yes and at the same time along with the government will also regulate the price of these products and will increase the cost by 10 - 100 times what they were originally via taxation. Look what they did with tobacco and cigarettes.

 

[jambi]

Flavorings marketed towards vaping are included...

I did see that. I'm not worried about flavorings from biggies. Cottage stuff like Liquid Barn, OSDIY, etc. will likely be gone though.

 

[dannyv45]

It's a gray area right now as to how it will effect the small shops. If they sell a manufactures product such as TFA that has FDA approval they may not be effected at all but if they rebottle or combine and repackage then they may need to get approval. And if a manufacture has an FDA approval for a flavor used as food flavoring such as capella do they need to get it approved as a vapor flavoring. And what about imports such as Hangsen or inawera are they going to seek approval to sell in the US or is it up to the individual seller. It's still unfolding and very fluid at the moment we will need to wait and see.

 

[ColoKaren]

Still don't have a feel for how or if the FDA will regulate batteries like 18650s, etc. after reading the entire document.

 

[dannyv45]

Still don't have a feel for how or if the FDA will regulate batteries like 18650s, etc. after reading the entire document.

I think there talking about batteries with embedded carto attachments and blue or red LED's on the end such as whats pictured above as well as adjustable box mods with build in non removable batteries. I don't see how they can regulate removable batteries such as 18650's

We still have time to stock up. THis whole deal is going to be phased in over the next 2 years.

 

[ColoKaren]

Yeah, I read some comment that regulating replaceable batteries would be difficult, and something about following voluntary something or other. Here's the quote:

FDA agrees that it is not necessary to regulate batteries that are not intended or reasonably expected to be used with a tobacco product under its tobacco product authorities. However, it is important that batteries that are co-packaged with other parts of an ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably expected to be used with ENDS are components subject to FDA's tobacco product authorities. FDA remains concerned about reports of exploding e-cigarette batteries and finds that regulating them can help address these problems. Toward that end, elsewhere in this issue of the Federal Register, FDA has made available draft guidance, which when final will describe FDA's current thinking regarding some appropriate means of addressing the premarket authorization requirements for newly deemed ENDS products, including compliance with existing voluntary standards for ENDS batteries.